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Trial History Detail on 2007-07-27

CUHK_CCT00132

2007-07-27

Retrospective

Department of Ophthalmology and Visual Sciences

Nil

Nil

Prof Dennis SC Lam

dennislam_cu-res@cuhk.edu.hk

email

Prof Dennis SC Lam

dennislam_cu-res@cuhk.edu.hk

email

Effect of Different Dosages of Intravitreal Bevacizumab (Avastin) in the Treatment of Diabetic Macular Edema: A Randomized Controlled Trial

Yes

2006-09-12

Diabetic Macular Edema

Drug

1.25mg intravitreal bevacizumab at monthly

3 months

2.5mg intravitreal bevacizumab

Inclusion Criteria: 1. Aged 18 years or older 2. Clinically significant macular edema (CSME) defined according to the ETDRS:- Retinal thickening at or within 500µm of the center of the macula; or - Hard exudates at or within 500µm of the center of the macula associated with adjacent retinal thickening; or - A zone or zones of retinal thickening of one disc area in size and at least part of which is within one disc diameter of the center of fovea 3. Macular edema of at least 250µm involving the fovea, as documented on optical coherent tomography (OCT) 4. Patients with best-corrected visual acuity of better than 1.3 ETDRS logMAR units 5. Patients physically fit to receive intravitreal injection 6. Informed consent Exclusion Criteria: 1. Ocular diseases other than cataract, CSME and refractive error, which includes: a. Any conditions known to cause macular edema, including retinal vein or artery occlusion, uveitis, premacular fibrosis, retinitis pigmentosa, macular hole and choroidal neovascularization b. Fibrovascular proliferation with or without tractional retinal detachment; c. Glaucoma and ocular hypertension 2. Proliferative diabetic retinopathy 3. Media opacities which affect fundus examination or OCT measurements 4. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens insertion 5. Any laser procedure within 4 months; or cataract extraction or intravitreal triamcinolone injection within 6 months 6. Pregnant patients 7. Failure to comply with follow up schedule 8. Presence of a non-healing wound, ulcer, fracture, or any medical condition associated with bleeding 9. ¡§Single eye¡¨ patient with fellow eye having best-corrected visual acuity of 20/400 or worse. 10. History of fluorescein allergy 11. Macular ischemia on fluorescein angiography

Randomized

Active

Double-blind

Parallel

2006-10-01

52

Complete

Best-corrected visual acuity at 6 months

1. Retinal thickness measured by optical coherent tomography (OCT) at each visit 2. Proportion of patients with moderate visual loss at 6 months 3. Proportion of patients with stable or gain in vision at 6 months 4. Intraocular pressure measured by non-contact tonometry (NCT) at each visit 5. Changes in macular function as measured by multifocal electroretinography (mfERG) at each visit 6. Changes in fluorescein angiography at 6 months 7. Change in levels of aqueous VEGF, PEDF and other growth factors / cytokines during the study period

No

2013-01-14


Yes

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